ANIL KUMAR PAGIDIPALLI
DUBLIN
Summary
Quality Assurance Analyst with 3 years of progressive experience in the pharmaceutical industry, specializing in QA operations and compliance. Demonstrated success in ensuring cGMP and GDP compliance, managing sampling and release of materials, handling deviations and CAPAs, and overseeing supplier/customer defect systems. Proven track record of delivering high-quality results under tight deadlines with strong attention to detail and regulatory accuracy. Highly skilled quality assurance analyst with significant experience in software testing, bug tracking, and resolution. Strong understanding of diverse QA methodologies and tools, demonstrating capability to implement comprehensive testing strategies. Proven ability to work collaboratively with development teams to improve overall product quality and performance. Exceptional problem-solving skills leading to successful project completion within stringent deadlines.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Quality Assurance Analyst
Sarvotham care pvt ltd
Hyderabad
04.2020 - 12.2021
- Line review of raw material, batch manufacturing records, and analytical reports related to validation & commercial manufacturing reports.
- Review and approval of laboratory events, deviation investigations, and CAPAs. Document distribution, review, retrieval, and master copy maintenance.
- Ensuring area cleanliness and removal of previous batch materials from the dispensing/manufacturing/packing areas.
- Conducted in-process checks and provided environmental monitoring assistance, documenting results to support trending analysis.
- Maintained retain samples and updated the Product Quality Review (PQR) database post QP release. Interfaced with suppliers/customers for Certificates of Analysis/Conformance and artwork approvals.
- Executed line clearance procedures compliant with GMP, reviewing logbooks, LUMAC logs, and stock cards to ensure operational integrity.
- Supported validation activities and participated in deviation investigations and CAPA implementation.
- Identified training needs, coordinated staff training sessions, and ensured compliance with health & Line clearance for dispensing of raw and packing materials. Line clearance to bulk/finished product filling and packing.
- Maintaining records of pre-dispatch inspection fill volume and quality check of the finished product.
- Performed AQL sampling and visual inspections during packaging and labeling activities. Review electronic data and electronic signature requirements during computer system validation of LIMS and other standalone software laboratories.
- Update and distribution of internal and external department documentation. Work with the quality team and management to develop, implement, and maintain the Quality Management System (QMS) following industry standards.
- Executed thorough reviews of batch manufacturing records, ensuring compliance and enhancing product quality across validation processes.
- Maintained accurate records during pre-dispatch inspections, enhancing traceability of quality checks for finished products.
- Managed incoming raw materials and in-process products during monthly production cycles.
QA Analyst
Hetero Labs Limited
Hyderabad
12.2018 - 03.2020
- Performed QA sampling, inspection, and approval of incoming raw materials, packaging components, and finished pharmaceutical products in accordance with cGMP and company SOPs.
- Verified and requested Certificates of Analysis (CoA) / Certificates of Conformance (CoC) for all received materials; ensured alignment with approved specifications prior to release. Maintained accurate sampling records, controlled documentation, and archived retain samples as per regulatory and internal requirements.
- Managed and reviewed acetates and artwork samples used in product packaging and labeling; ensured compliance with regulatory and marketing specifications.
- Reviewed and approved Master Packaging Material Specifications (MPMS); ensured accuracy and consistency with artwork and regulatory files.
- Conducted regular warehouse housekeeping inspections and audits; documented findings and followed up on corrective actions to maintain inspection readiness.
- Identified QA training needs for warehouse personnel and delivered training sessions on cGMP, GDP, hygiene, sampling, and deviation handling.
- Oversaw the Supplier/Customer Defect (SCD) management process: issued SCD numbers, tracked investigations with suppliers/customers, and ensured timely resolution and closure. Handled deviation reporting, root cause analysis, and implementation of corrective and preventive actions (CAPAs) in coordination with cross-functional teams.
- Supported validation activities (e.g., cleaning validation, warehouse equipment qualification) by providing QA oversight and ensuring documentation compliance. Maintained high cGMP standards and ensured all warehouse QA activities were aligned with FDA, EMA, and company quality policies.
- Promoted a strong safety culture; reported hazards promptly and participated in Health & Safety meetings and risk assessments.
- Performed other QA-related tasks to support continuous improvement and operational excellence within the warehouse and production interface.
Pharmacist
Jyothi multiJyothiMultispecialty Hospital
Suryapet
02.2015 - 10.2018
- Maintained accurate drug records and generated necessary reports for compliance.
- Interpreted prescription orders, dispensed medications, and counseled patients on proper usage.
- Educated patients on potential drug interactions and provided special administration instructions.
- Vaccinated patients to ensure immunity against influenza, pneumonia, and other diseases.
- Affixed correct labels to guide patients on medication intake per healthcare provider recommendations.
- Prepared medications in blister packs for safe and convenient administration.
- Reviewed prescriptions to confirm appropriate drug selection and check for interactions.
- Assisted patients in overcoming vaccine hesitancy through sharing efficacy and safety data.
Education
PG DIPLOMA - PHARMACEUTICAL BUSINESS AND TECHNOLOGY
Grith College Dublin
Dublin, Ireland09-2024
MASTER OF SCIENCE - PHARMACEUTICS
Venkateshwara Institute of Pharmaceutical Science
INDIA01-2014
Skills
- Cross-functional collaboration
- Technology transfer and process validation
- Artwork review
- Warehouse management
- Quality assurance
- cGMP compliance
- GDP compliance
- Equipment qualification and validation
- Sampling techniques
- CAPA management
- Batch review
- Quality systems oversight
- Internal audits
- Document management
- Regulatory audits
- Change control processes
- 21 CFR Part 11 compliance
- Area qualification and requalification
- AQL standards
Certification
- Registered Pharmacist
- Rainbow QA Training certification
References
References will be available on request.
Timeline
Quality Assurance Analyst
Sarvotham care pvt ltd
04.2020 - 12.2021
QA Analyst
Hetero Labs Limited
12.2018 - 03.2020
Pharmacist
Jyothi multiJyothiMultispecialty Hospital
02.2015 - 10.2018
PG DIPLOMA - PHARMACEUTICAL BUSINESS AND TECHNOLOGY
Grith College Dublin
MASTER OF SCIENCE - PHARMACEUTICS
Venkateshwara Institute of Pharmaceutical Science